prostate cancer
Conditions
Interventions
dutasteride+abiraterone:dutasteride+abiraterone
placebo+abiraterone:abiraterone
Sponsors
Shanghai Tongji Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Patients over the age of 18 who signed the informed consent; 2. Prostate adenocarcinoma was confirmed by histology or cytology; 3. Patients were castrated resistant prostate cancer patients (serum testosterone = 12 months; 6. Patients were able to swallow the study drug and comply with the study requirements; 7. Patients agree to use condoms and other effective contraceptive methods having sex with a fertile woman; 8. Patients agreed not to participate in other intervention studies during the treatment period.
Exclusion criteria
Exclusion criteria: 1. Patients had previously received new androgen receptor inhibitors such as enzalutamide or apalutamide; 2. The histologic features were special types such as small cell carcinoma of prostate, sarcoma of prostate, and so on; 3. Patients had a history of aggressive cancer within 3 years before screening; 4. At the time of screening, total bilirubin >= 1.5 * normal upper limit or alanine aminotransferase >= 2.5 * normal upper limit; 5. The creatinine of the subjects was more than 442 umol / L at the time of screening; 6. Subjects were in active infection or other medical conditions in which prednisone was contraindicated; 7. At the time of screening, the patients had uncontrolled hypertension (systolic blood pressure > 170 mmHg or diastolic blood pressure > 105 mmHg for at least two consecutive blood pressure measurements).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| progression-free survival;PSA decrease range;overall survival;bone events;liver function; | — |
Countries
China
Contacts
Public ContactWU DENGLONG
Shanghai Tongji Hospital
Outcome results
None listed